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marzan

05/25/16 3:05 PM

#81275 RE: HDGabor #81273

what a beautiful analysis! Thanks HDG!! Looks like Stoppage at the Interim is unavoidable.
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Whalatane

05/25/16 3:18 PM

#81278 RE: HDGabor #81273

Gabor Excellent work


I need a few more espresso's before I compose a response ...:>)

Actually , on the road to Napa valley .
Doing some research into the bottle of wine I might need to buy you if R-IT is stopped.
We've planned a 2 day tasting tour of the various wineries .
I should have found some thing good by then ..:>)

Kiwi
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Whalatane

05/26/16 12:28 AM

#81329 RE: HDGabor #81273

Gábor ..quick note ( from wine country ) re your post.
Excellent detail by the way.
The 1050 patients with prior MI (JELIS 2ndary )
The placebo rate of was 4.37 with an estimated 2 gms of Serum EPA and Simvastatin
Add 1.8gms of Epadel ( now total about 4 gms serum EPA ) and event rate drops about 26% to 3.7 % event rate

So , back of the envelope , roughly 2gms of EPA drops event rate by 25%..... So the same group on Simvastatin but 0 serum EPA would have an event rate of about 5.8 %
( 25% of 5.8% = 1.45 % ....
2gms of EPA = 25% reduction in the MI population on Simvastatin.)

5.8% - 1.45 % = 4.35 % = the placebo rate in the MI group in JELIS
So we can say that adding 2 gms of EPA to this placebo Simvastatin population with 0 serum EPA lowers their event rate to 4.37% and an additional 2 Gms of EPA will lower event rate further to 3.7 %

So using JELIS data with Simvastatin and a mean LDL level of 178 it easy to see how 4 gms of serum EPA would lower your cv event risk by over 30%

But R-it is using optimal dose Crestor and Lipitor and a mean LDL level of probably around 90 .
So R-IT placebo level is likely to have significantly lower CV event risk then a JELIS 2ndry MI type population on low dose Simvastatin and 0 serum EPA

If we accept this R-It placebo rate at 5.2% , can we expect the same RRR we saw in same population in JELIS ..in total an RRR of over 30% by adding a total of 4 gms of EPA .

We are starting at a lower base placebo rate .
I don't think we are going to get the same magnitude of effect

Just my thoughts tonight
May think different in the am :>)
Kiwi